Roche Pharmacovigilance Inspection Results
The EMA finalized its review of medicines in a pharmacovigilance inspection of all medicines manufactured by Roche.
The EMA finalized its review of medicines in a pharmacovigilance inspection of all medicines manufactured by Roche. The review was initiated following a routine pharmacovigilance inspection in early 2012.
Last year’s inspection identified some safety data that the company had failed to submit, and the EMA was keen to examine whether these further data had any impact on the balance of benefits and risks of these medicines. Included in this review were 19 centrally authorized medicines, as well as various medicines that have been nationally authorized.
“The assessment by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) of the impact of the additional data provided by Roche on the medicines concerned has not identified any important new safety concerns. The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use,” EMA pointed out. “Patients should continue to take these medicines as previously advised.”
The Agency’s Committee for Medicinal Products for Human Use (CHMP) agreed with the conclusions of the PRAC. However, as Roche continues to provide additional data as part of the obligatory follow-up, the company is required to ensure that these data are included and considered in their routine pharmacovigilance activities, including the periodic cumulative reviews of the benefits and risks of these medicines.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
